Clinical Project Manager
4 weeks ago
For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies.
As the world's largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs.
We're looking for a Clinical Project Manager to support ProPharma in providing strategic and tactical operational planning and execution on a number of upcoming studies. You will be responsible for oversight and conduct of clinical research trials, ensuring they are executed in accordance with applicable regulations and that the quality of clinical data generated meets the requirements for Regulatory Authority approval. This role is offered on a fully remote, full-time, permanent basis.
Key Responsibilities
- Plans and manages assigned studies from start to close out.
- Managing project timelines and project budget.
- Proactively anticipates and understands concerns/issues/delays.
- Develops risk assessments and contingency plans.
- Holds each functional area responsible for associated risk mitigation and management.
- Primary source of communication for the clinical project team, cross-functional project teams, and internal and external stakeholders.
- Participates in project kick-off meetings.
- Provides regular updates to clients and manages communication between team members and clients.
- Monitors project budget vs. cost and ensures project margins are met.
- Provide study-specific training for clinical operations staff as appropriate.
- Evaluate and identify resourcing needs and monitor over the lifecycle of the study.
- Develop, analyze, and report study metrics to Sponsor per Project Plan and proactively identify and communicate any risks or concerns.
- Develop and maintain Study Project Plans.
- Provide strategic input into study documents.
- Manages study drug product and non-drug site supplies.
- Develops the agenda and manages the planning and execution of Investigator Meetings.
- Responsible for the development and presentation of slides and training materials for various audiences.
- Assists with vendor selection (ECG, Lab, IWRS, IRB, Raters) and contracting.
- Ensures clinical study team compliance with applicable FDA / ex-US regulations, ICH-GCPs, other local regulatory requirements, and corporate SOPs.
- Develop subject recruitment/retention strategy and related initiatives for assigned studies.
- Oversee maintenance and quality review of study TMF.
Qualified Candidates Will Have:- Relevant Bachelor's degree or advanced degree (e.g., Master, PharmD, PhD). Candidates with equivalent combination of education, training, and experience will be considered.
- Several years of clinical trial and research experience.
- Knowledge of FDA and/or ex-US Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials.
- Experience managing/mentoring and developing junior staff.
- Demonstrated experience in change management initiatives.
This role sits within our Clinical Operations Team. We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.
- Relevant Bachelor's degree or advanced degree (e.g., Master, PharmD, PhD). Candidates with equivalent combination of education, training, and experience will be considered.
-
Clinical Study Manager
31 minutes ago
London, Greater London, United Kingdom MAC Clinical Research Full timeAbout the RoleWe are seeking a highly skilled and experienced Clinical Study Manager to join our team at MAC Clinical Research. As a Clinical Study Manager, you will be responsible for managing our Clinical Monitoring team and contributing to the growth and development of our clinical services.Key ResponsibilitiesProvide line management to the Clinical...
-
London, Greater London, United Kingdom Advanced Clinical Full timeJob SummaryWe are seeking a highly experienced and skilled Senior Director, Clinical Research Scientist to join our team at Advanced Clinical. This is a key leadership role that will be responsible for collaborating with physicians in Clinical Development to deliver clinical research support for assigned programs.Key ResponsibilitiesProtocol...
-
London, Greater London, United Kingdom Advanced Clinical Full timeJob SummaryWe are seeking a highly experienced and skilled Senior Director, Clinical Research Scientist to join our team at Advanced Clinical. This is a key leadership role that will be responsible for collaborating with physicians in Clinical Development to deliver clinical research support for assigned programs.Key ResponsibilitiesProtocol...
-
Clinical Monitoring Director
3 days ago
London, Greater London, United Kingdom MAC Clinical Research Full timeAbout the RoleWe are seeking a highly skilled Clinical Monitoring Manager to lead our Clinical Monitoring team and drive the growth and development of our clinical services. Reporting to the Head of Global Clinical Operations, this is a fantastic opportunity to make a positive impact on our progressive CRO company.Key ResponsibilitiesProvide line management...
-
Clinical Monitoring Director
3 days ago
London, Greater London, United Kingdom MAC Clinical Research Full timeAbout the RoleWe are seeking a highly skilled Clinical Monitoring Manager to lead our Clinical Monitoring team and drive the growth and development of our clinical services. Reporting to the Head of Global Clinical Operations, this is a fantastic opportunity to make a positive impact on our progressive CRO company.Key ResponsibilitiesProvide line management...
-
Clinical Project Manager
4 weeks ago
London, Greater London, United Kingdom The George Institute for Global Health Full timePosition DescriptionCAREER STEP: Projects / IndependentREPORTING RELATIONSHIP: Operations Manager, Clinical TrialsTEAM: UK, Centre for Operational and Research Excellence (CORE)EMPLOYMENT DURATION: Length of project- 2 years START DATE: ASAPAbout The George InstituteThe George Institute for Global Health was established in 1999 with a mission to improve the...
-
Regulatory Medical Writer
6 days ago
London, Greater London, United Kingdom MAC Clinical Research Full timeJob SummaryWe are seeking a highly skilled Medical Writer to join our team at MAC Clinical Research. As a Medical Writer, you will play a critical role in the development of clinical documents for submission to regulatory authorities.Key ResponsibilitiesServe as Medical Writer for allocated projects, confident to represent the Medical Writing function in...
-
Medical Writer
6 days ago
London, Greater London, United Kingdom MAC Clinical Research Full timeJob SummaryWe are seeking a highly skilled Medical Writer to join our team at MAC Clinical Research. As a Medical Writer, you will play a critical role in the development of clinical documents for submission to regulatory authorities.Key ResponsibilitiesServe as Medical Writer for allocated projects, confident to represent the Medical Writing function in...
-
Clinical Research Agreements Manager
3 weeks ago
London, Greater London, United Kingdom MAC Clinical Research Full timePosition Overview:We are currently looking for a Clinical Research Agreements Manager to join our committed legal team.The Clinical Research Agreements Manager will play a crucial role in overseeing and facilitating the examination, formulation, and negotiation of various contracts, including but not limited to master service agreements, standalone...
-
Senior Medical Writer
3 days ago
London, Greater London, United Kingdom MAC Clinical Research Full timeAbout the RoleWe are seeking a highly skilled and experienced Senior Medical Writer to join our team at MAC Clinical Research. As a Senior Medical Writer, you will play a critical role in the development and delivery of high-quality clinical study documents, including protocols, investigator brochures, informed consent forms, and clinical study reports.Key...
-
Senior Medical Writer
3 days ago
London, Greater London, United Kingdom MAC Clinical Research Full timeAbout the RoleWe are seeking a highly skilled and experienced Senior Medical Writer to join our team at MAC Clinical Research. As a Senior Medical Writer, you will play a critical role in the development and delivery of high-quality clinical study documents, including protocols, investigator brochures, informed consent forms, and clinical study reports.Key...
-
Senior Medical Writer
5 hours ago
London, Greater London, United Kingdom MAC Clinical Research Full timeJob DescriptionJob Title: Senior Medical Writer - Clinical ResearchJob Summary:We are seeking a highly skilled and experienced Senior Medical Writer to join our team at MAC Clinical Research. As a Senior Medical Writer, you will be responsible for creating high-quality clinical study documents, including protocols, informed consent forms, and clinical study...
-
Senior Medical Writer
2 hours ago
London, Greater London, United Kingdom MAC Clinical Research Full timeJob DescriptionJob Title: Senior Medical Writer - Clinical ResearchJob Summary:We are seeking a highly skilled and experienced Senior Medical Writer to join our team at MAC Clinical Research. As a Senior Medical Writer, you will be responsible for creating high-quality clinical study documents, including protocols, informed consent forms, and clinical study...
-
Senior Medical Writer
4 days ago
London, Greater London, United Kingdom MAC Clinical Research Full timeJob DescriptionJob Title: Senior Medical Writer - Clinical ResearchJob Summary:We are seeking a highly skilled and experienced Senior Medical Writer to join our team at MAC Clinical Research. As a Senior Medical Writer, you will be responsible for creating high-quality clinical study documents, including protocols, informed consent forms, and clinical study...
-
Senior Medical Writer
4 days ago
London, Greater London, United Kingdom MAC Clinical Research Full timeJob DescriptionJob Title: Senior Medical Writer - Clinical ResearchJob Summary:We are seeking a highly skilled and experienced Senior Medical Writer to join our team at MAC Clinical Research. As a Senior Medical Writer, you will be responsible for creating high-quality clinical study documents, including protocols, informed consent forms, and clinical study...
-
Senior Clinical Project Manager
1 month ago
London, Greater London, United Kingdom Cpl Full timeSenior: Clinical Project Manager Location: Fully remote UK basedContract length: 12 months FTCSalary: k per annumOncology experience: phase II - IIIASAP startCpl are working with a fantastic small growing Biotech now looking for a Senior Clinical Project Manager to join their team - please note: high flexibility is required and you must have worked on the...
-
Head of Asset Management
5 days ago
London, Greater London, United Kingdom WEP Clinical Full timeJob Title: Head of Asset ManagementDepartment: Project Management - Expanded Access Programs / Post-Approval Named Patient ProgramsLocation: Hybrid/OnsiteWEP Clinical is a market leader in Expanded Access Programs (EAP) & Post-Approval Named Patient Programs. We are a team of experts with over 15 years of experience, having distributed medicines in over 120...
-
Senior Medical Writer
7 hours ago
London, Greater London, United Kingdom MAC Clinical Research Full timeJob DescriptionJob Title: Senior Medical WriterJob Summary:We are seeking a highly skilled and experienced Senior Medical Writer to join our team at MAC Clinical Research. As a Senior Medical Writer, you will be responsible for creating high-quality clinical documents, including protocols, informed consent forms, and clinical study reports, for submission to...
-
Senior Medical Writer
4 hours ago
London, Greater London, United Kingdom MAC Clinical Research Full timeJob DescriptionJob Title: Senior Medical WriterJob Summary:We are seeking a highly skilled and experienced Senior Medical Writer to join our team at MAC Clinical Research. As a Senior Medical Writer, you will be responsible for creating high-quality clinical documents, including protocols, informed consent forms, and clinical study reports, for submission to...
-
Project Manager
2 weeks ago
London, Greater London, United Kingdom NHS England Full timeAbout the RoleThe NHS England board has set out the top-level purpose for the new organisation to lead the NHS in England to deliver high-quality services for all. As a Project Manager within the Clinical & Quality team, you will work as part of a dynamic and supportive multidisciplinary team in delivering safe, effective and evidence-based services.Key...
